Smoking represents an enormous public health problem, and yet in spite of widespread agreement about the deleterious health effects of tobacco to the smoker from atherosclerotic vascular disease, cancer, and chronic obstructive pulmonary disease, to the non-smoker from second-hand smoke, and to society which bears most of the expense of smoking-related illness, the practice continues and actually is increasing among adolescents and minorities and in certain parts of the world. The view of cigarette smoking as compulsive behavior in the face of negative consequences can also be applied to other compulsions related to caffeine consumption, eating of sugar or fat-laden foods, abuse of alcohol, barbiturates, recreational and illicit drugs and narcotics.
Smoking is as much a habit as it is a behavior which is why a multimodal approach, rather than a single strategy, is often necessary to treat this complex behavior. A multimodal approach also often forms the basis of the treatment of other compulsive behaviors such as overeating, drinking alcohol and taking drugs. In short, since all individuals with detrimental or compulsive habits do not share the same triggers, the relative efficacy of any one treatment depends on the person trying to quit. It follows therefore that the more options available to these individuals the greater the likelihood of success. For example, the conventional wisdom is that tobacco abuse is primarily fueled by nicotine dependence, and while this may be at the core of the addiction, other smoking-related stimuli, in particular, the taste and flavor of a cigarette, can accentuate the nicotine buzz and trigger the craving for a smoke.
The most consistent clinical benefit for smoking comes from pharmacologic strategies including nicotine replacement in the form of patches, gum and lozenges, antidepressants such as Buproprion, and, most recently, a nicotine receptor stimulant called Varenicline which, according to a Cochrane review article, nearly triples the odds of stopping smoking. However, these pharmacologic anti-smoking remedies can be expensive, generally have unwanted side effects and, moreover, given the complex nature of smoking, their efficacy is not always guaranteed. The same can often be said of anti-alcohol, anti-drug, and anti-obesity remedies.
It is therefore an object of the present invention to provide formulations for use in reducing addictions while avoiding the side effects of the known prescription anti-smoking, anti-alcohol, anti-drug, and anti-obesity remedies.
It is a further object of the invention to provide formulations over-the-counter formulations, which do not contain any “active” ingredients requiring regulatory approval as a new drug.
It is still another object of the present invention to provide formulations which can be used repeatedly and reacts with cigarettes, food, caffeine, drugs, alcohol and other tobacco products to leave behind an unpleasant taste or sensation while providing oral and manual stimulation to replace the rituals of tobacco, drugs, caffeine, alcohol, or food.